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The InVision 1.5 Surgical Theatre is indicated for use as a magnetic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and that displays the internal structure and/or function of the head, body or extremities.

Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, contrast agents may be used. These images and/or spectra and the physical parameters derived from the images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.

The InVision 1.5 Surgical Theatre may also be used for imaging during intraoperative and interventional procedures when performed with MR safe devices or MR conditional devices approved for use with the MR scanner.

The InVision 1.5 Surgical Theatre may also be used for imaging in a multi-room suite.

The proposed InVision™ 1.5 Surgical Theatre is a traditional Magnetic Resonance Imaging (MRI) scanner that is suspended on an overhead rail system. It is designed to operate inside a Radio Frequency (RF) shielded room to facilitate intraoperative and multi-room use. The InVision 1.5 Surgical Theatre uses a scanner, the Siemens MAGNETOM Sola (K203443, reference device), to produce images of the internal structures of the head as well as the whole body. The Siemens 1.5T MAGNETOM Sola MRI scanner is an actively shielded magnet with a magnetic field strength of 1.5 Tesla.

The InVision 1.5 Surgical Theatre provides surgeons with access to magnetic resonance (MR) images while in the surgical field without changing the surgical/clinical workflow. When images are requested in the operating room (OR), the magnet is moved from the diagnostic room (DR) to the OR on a pair of overhead rails while the patient remains stationary during the procedure. Imaging is performed and once complete the magnet is moved out of the OR to the DR. The magnet can be moved in and out of the surgical field multiple times, as required, throughout the course of the surgical procedure. When the Siemens MAGNETOM Sola MRI scanner is in the DR, the OR may be used as a standard OR, utilizing standard surgical instruments and equipment during surgery. When not required in the OR, the scanner is available for use in the DR as a standard diagnostic MRI.

This document primarily focuses on the substantial equivalence of a new medical device, the InVision™ 1.5 Surgical Theatre, to a previously cleared predicate device, the IMRIS iMRI 3T V. The information provided is characteristic of a 510(k) premarket notification to the FDA, which aims to demonstrate that a new device is as safe and effective as an already legally marketed device, and not a study proving the device meets specific acceptance criteria typical of an AI/ML software performance study.

Therefore, many of the specific details requested in the prompt, such as acceptance criteria in terms of AI model performance metrics (e.g., sensitivity, specificity, AUC), sample size for test sets directly related to AI performance, expert adjudication methods for ground truth, MRMC studies, or standalone algorithm performance, are not applicable or present in this document. This submission is for a physical medical device (an MRI scanner system with a moving gantry), not an AI/ML software.

However, I can extract information related to the device's validation and comparison to its predicate:

Acceptance Criteria and Device Performance (as per 510(k) for a physical device):

The "acceptance criteria" in this context are related to demonstrating substantial equivalence to a predicate device. This is achieved by showing that the new device has the same intended use and similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness. The performance is assessed through non-clinical testing to ensure it meets safety and functional standards, and maintains clinically acceptable imaging performance.

1. Table of acceptance criteria and the reported device performance:

Since this is a physical device and not an AI/ML software, the "acceptance criteria" are not reported as specific performance metrics like sensitivity/specificity for an algorithm. Instead, they relate to regulatory and functional compliance.

Differences and Rationale:

• Siemens MRI System: Proposed uses Siemens 1.5T MAGNETOM Sola (K203443) vs. Predicate's Siemens 3T MAGNETOM Vida (K192924).
• Static Field Strength: Proposed 1.5 Tesla vs. Predicate 3 Tesla.
• IMRIS Intraoperative Imaging Coils: HC150 Coil and InSitu Coil 1.5T vs. HC300 Coil and InSitu Coil 3T.
  These differences are assessed through non-clinical testing (functional, imaging performance, integration, software verification, acoustic energy analysis, heating verification) to ensure equivalent safety and performance. |
  | Compliance with Recognized Consensus Standards | All listed FDA recognized consensus standards (Table 2 on page 10-11) were conformed to. This includes standards for medical electrical equipment (safety, EMC), risk management, usability engineering, software life cycle processes, acoustic noise measurement, characterization of phased array coils, SNR/image uniformity, biocompatibility, and sterilization. |
  | Clinically Acceptable MR Imaging Performance | "Successful completion of the standard Siemens OA tests and expert review of sample clinical images demonstrates that the InVision 1.5 Surgical Theatre maintains clinically acceptable MR imaging performance within both the DR and OR(s)." |
  | Safety and Performance Profile Equivalent to Predicate | "The verification and validation testing of the InVision 1.5 Surgical Theatre support a determination of substantial equivalence." "The InVision 1.5 Surgical Theatre technological characteristics do not raise different questions of safety and effectiveness." |

2. Sample sized used for the test set and the data provenance:

• Test Set (Non-Clinical): The document refers to "Performance Testing" on the "InVision 1.5 Surgical Theatre (finished device) and applicable components and hardware" (Table 3, page 12). This indicates the testing was performed on the actual device hardware.
• Sample Clinical Images: "Sample Clinical Images in DR and OR" were assessed, as required by the guidance for Magnetic Resonance Diagnostic Devices. The number of images or patient cases is not specified.
• Data Provenance: Not explicitly stated, but given it's a medical device for US market clearance, typically such testing involves internal data or data collected under controlled conditions to demonstrate device functionality and safety. It's safe to assume it's retrospective, as it involves "sample clinical images" for assessment rather than a prospective clinical trial. Country of origin is not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• The document mentions "expert review of sample clinical images." The number of experts and their specific qualifications (e.g., years of experience) are not specified.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• No specific adjudication method is described for the "expert review of sample clinical images."

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No, an MRMC study was not done. This submission is for a physical MRI device, not an AI-assisted diagnostic software.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable. This isn't an AI algorithm. The performance being assessed is the image acquisition capability of the MRI system, which a human clinician interprets.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• For the "sample clinical images" assessed, the "ground truth" for image quality and clinical acceptability was based on expert review. This is typical for demonstrating image quality of a diagnostic device. Since it's an MRI system, the "truth" is whether the images accurately represent the internal structure and/or function for diagnosis, as interpreted by a trained physician. It's not about diagnosing specific diseases with a "pathology" ground truth, but rather about the diagnostic quality of the images produced.

8. The sample size for the training set:

• Not applicable. This is a physical device, not an AI/ML model that requires a "training set."

9. How the ground truth for the training set was established:

• Not applicable. As stated above, there is no AI/ML training set in this context.

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The IMRIS iMRI 3T V is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that displays the internal structure and/or function of the head, body or extremities.

Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, contrast agents may be used. These images and/or spectra and the physical parameters derived from the inages and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.

The IMRIS iMRI 3T V system may also be used for imaging during intra-operative and interventional procedures when performed with MR safe devices or MR conditional devices approved for use with the MR scanner.

The IMRIS iMRI 3T V MRI systems may also be used for imaging in a multi-room suite.

The IMRIS iMRI 3T V is a traditional MRI unit that has been suspended on an overhead rail system, and is designed to operate inside an RF shielded room to facilitate intra-operative and multi-room use. The magnet is normally situated in a Diagnostic Room (DR) until imaging is requested. The system retains all standard diagnostic features of an MRI system in the DR. The DR is separated from the intra-operative Operating Room (OR) by sliding doors that are part of the facility structure.

The IMRIS iMRI 3T V is a tool for radiologists and surgeons, used to acquire images for diagnostic, intraoperative, or interventional procedures. For OR purposes, high-resolution images can be obtained immediately prior to surgical incision, intraoperatively, and after wound closure. The IMRIS iMRI 3T V is based on the IMRIS iMRI 3T S cleared under 510(k) K133692 and the Siemens MAGNETOM Vida MRI system cleared under 510(k) K192924. The major components of the IMRIS iMRI 3T V system are: the Siemens MAGNETOM Vida MRI system with minor modifications, IMRIS Magnet Mover System, RF coils, Application platform, OR Table Assembly, Head fixation device, IMRISeye, and Horseshoe headrest.

Here's a summary of the acceptance criteria and the study information for the IMRIS iMRI 3T V system, based on the provided text:

Acceptance Criteria and Device Performance

The FDA clearance document for the IMRIS iMRI 3T V system does not explicitly detail a table of specific numerical acceptance criteria and corresponding reported device performance values in the way one might see for an AI algorithm's sensitivity/specificity. Instead, the "acceptance criteria" are implied by the successful completion of design verification and validation tests against established standards and the confirmation of "sufficient quality for diagnostic use" by radiologists.

Study Details

1. Sample sizes used for the test set and data provenance:

   • The document mentions "a number of V&V tests" and that images were produced and confirmed by radiologists, but it does not specify the sample size (number of images, cases, or patients) used for a distinct test set for image quality evaluation.
   • Data Provenance: Not specified. The document does not indicate the country of origin of the data or whether it was retrospective or prospective.

2. Number of experts used to establish the ground truth for the test set and their qualifications:

   • The document states, "Board certified Radiologist confirmation that images produced by the device are of sufficient quality for diagnostic use."
   • Number of Experts: Singular ("Radiologist") is used, implying at least one board-certified radiologist. The exact number is not provided.
   • Qualifications: "Board certified Radiologist". (No specific years of experience are mentioned).

3. Adjudication method for the test set:

   • Not specified. The document only mentions "Board certified Radiologist confirmation," but it does not detail a specific adjudication method like 2+1 or 3+1 if multiple radiologists were involved.

4. Multi Reader Multi Case (MRMC) comparative effectiveness study:

   • No, a MRMC comparative effectiveness study was not explicitly mentioned or described. The study focuses on demonstrating the substantial equivalence of the device to its predicate through compliance with standards and expert confirmation of image quality, rather than quantifying human reader improvement with/without AI assistance. The device is an MRI system, not an AI-powered diagnostic tool for interpretation.

5. Standalone (algorithm only without human-in-the-loop performance) study:

   • Yes, in the sense that the device's technical performance and image quality were evaluated independently. The "Board certified Radiologist confirmation" would be an assessment of the output (images) produced by the device itself, rather than an assessment of how well a human interprets those images with or without AI assistance. The device is a diagnostic imaging system, designed to produce images for human interpretation, not an AI algorithm for autonomous diagnosis.

6. Type of ground truth used:

   • Expert Consensus/Opinion: The ground truth for image quality was established by a "Board certified Radiologist confirmation" that images were of "sufficient quality for diagnostic use." This relies on expert interpretation and judgment. There's no mention of pathology or outcomes data being used for this specific evaluation.

7. Sample size for the training set:

   • Not applicable/Not specified. The IMRIS iMRI 3T V is a magnetic resonance diagnostic device (hardware system), not an AI algorithm that undergoes "training" on a dataset in the conventional machine learning sense for image interpretation. The "training" of the system would refer to its engineering, calibration, and adherence to established physical principles and specifications.

8. How the ground truth for the training set was established:

   • Not applicable. As above, this is a hardware device, not an AI algorithm model that learns from a labeled training set.

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